Recruiting

Blood Pressure Monitoring

Sponsor:

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Code:

NCT06688409

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

awake ABPM

Study Details

Brief summary:

This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory blood pressure monitoring.

Conditions

Hypertension

Study ID

NCT06688409

Start date

Feb 12, 2024

Status verified date

Feb, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults aged > 18 years scheduled to undergo an ABPM

Exclusion Criteria:

  • Upper arm size outside of cuff range of selected devices (<22 cm or >42 cm)
  • Night shift workers
  • Permanent atrial fibrillation
  • Known severe aortic stenosis
  • Contraindication to measure BP on the non-dominant arm
  • Ongoing pregnancy
  • Inability or unwillingness to provide consent

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Validate home BP device

BP measured with a validated home BP device

active comparator: Non-validated home BP device #1

BP measured with the first non-validated home BP device

active comparator: Non-validated home BP device #2

BP measured with the second non-validated home BP device

active comparator: Non-validated home BP device #3

BP measured with the third non-validated home BP device

Interventions

awake ABPM

Comparison of a BP measured with the home BP devices and the average awake ABPM performed immediately after

Primary outcome measure

  • Mean difference in systolic BP [ Time Frame: At enrollment (time 0) ]

Central Contacts and Locations

Central contacts

Remi Goupil, MD MSc

514-338-2883remi.goupil@umontreal.ca

Locations

Hôpital Sacré-Coeur de Montréal

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Contacts

Guylaine Marcotte

+1-514-338-2222guylaine.marcotte.cnmtl@ssss.gouv.qc.ca

More Information

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Last update posted

Feb 14, 2025

Last verified

Feb, 2025

Keywords

  • hypertension
  • blood pressure measurement
  • blood pressure
  • blood pressure device validation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal on 2025-02-14.